Comparison of Standing Versus Supine 3D Cone Beam Computed Tomography in Patient With Obstructive Sleep Apnea

NCT ID: NCT04874727

Last Updated: 2021-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-12-31

Brief Summary

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The anatomical changes of the upper airway in a standing vs pseudo-supine position using Carestream Orthodontic Imaging (Volumetric) and Carestream Orthodontic Imaging module (AP measurements) of the patient's airway respectively, have been taken and the obtained results compared. In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.

Detailed Description

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Conditions

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OSA Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Study Population

The five or six individual patients enrolled are the members of the sole group, the study population. These individuals all have been diagnosed with obstructive sleep apnea and have take a Cone-beam CT scan with and without the new bite technique.

Mandible slacked and captured with Correct Plus™ Impression Material Superfast

Intervention Type PROCEDURE

In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.

Interventions

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Mandible slacked and captured with Correct Plus™ Impression Material Superfast

In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Participant must be a patient of Dr. Maryam Bakhtiyari's orthodontic practice
* Participant must have a diagnosis of obstructive sleep apnea
* Participant must have an invitation to join research study from Dr. Bakhtiyari

Exclusion Criteria

* Participant cannot have a history of serious dental trauma
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manhattan Beach Orthodontics

OTHER

Sponsor Role lead

Responsible Party

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Dr. Maryam Bakhtiyari

Dentist, Owner

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Manhattan Beach Orthodontics

Manhattan Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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0002

Identifier Type: -

Identifier Source: org_study_id

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